Overview

Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

Status:
Completed
Trial end date:
2011-02-16
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Dacarbazine
Temozolomide
Criteria
Inclusion Criteria:

- Presence of a brain tumor with high probability of being a glioma as detected by
Magnetic Resonance Imaging (MRI). These would include newly diagnosed tumors or
potentially recurrent gliomas.

- No prior treatment for the tumor including chemotherapy or radiotherapy.

- Amenable to surgery for biopsy or resection of the brain tumor. Surgically confirmed
diagnosis of glioma (glioblastoma multiforme [GBM], anaplastic astrocytoma [AA],
anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA], astrocytoma [A]
or oligodendroglioma [O]) will be

required for patients to be maintained in the study. Those not fulfilling this requirement
will be discontinued and will be replaced.

- Use of medically approved contraception in fertile males and females.

- Women with childbearing potential must have a negative urine or serum

pregnancy test (urinary excretion or serum level of beta-Human Chorionic

Gonadotropin [bHCG]) within 72 hours of randomization.

- Karnofsky Performance Status score >= 70%.

- Signed informed consent form

Exclusion Criteria:

- Prior chemotherapy.

- Prior radiotherapy at the tumor site.

- History of non-compliance to other therapies.

- Inadequate haematological, renal and hepatic function according to all of the
following laboratory values (to be performed within 14 days, inclusive, prior to study
inclusion):

- Absolute neutrophil count ≤1.5 x 10^9/L;

- Platelets ≤100 x 10^9/L;

- Haemoglobin <90 g/L;

- Serum creatinine ≥1.5 times upper limit of laboratory normal;

- Total serum bilirubin ≥1.5 times upper limit of laboratory normal (ULN);

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ULN;

- Alkaline phosphatase of > 2.5 ULN.

- Known Human Immunodeficiency Virus [HIV] infection.

- Known chronic hepatitis B or hepatitis C infection.

- Any other serious medical condition according to the medical judgment of the physician
prior to inclusion in the study.

- Any medical condition, which could interfere with oral medication intake (e.g.,
frequent vomiting, partial bowel obstruction).